Optimizing Sleep Health in Nurses

Oregon State University60 enrolled

Overview

The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.

Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia therapies. The specific therapy for insomnia will be determine by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, both modified for shift workers. Both therapies will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Circadian Rhythm Sleep-Wake Disorders, Shift Work Type Sleep Initiation and Maintenance Disorders

Interventions

CBTIBEHAVIORAL

Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

MRTIBEHAVIORAL

Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Current shift working nursing staff in Oregon * Expect to continue on shift work schedule during the study * Meets criteria for an insomnia disorder * Elevated insomnia symptoms * Have daily access to internet on a smartphone, tablet, or computer; and * Can read and write in English Exclusion Criteria: * People with uncontrolled medical conditions * Presence of safety risk or condition in which study participation may be ineffective or result in increased risk to safety * Some current treatments for insomnia * Permanent day, evening, or rotating shift schedule * History of seizures or manic episode; or * Current/expected pregnancy during the study period

Locations (1)

Oregon State University

Corvallis, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Insomnia Severity Index

Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity

Time frame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

Retention Rate

Defined as \[number of participants who complete minimal therapeutic dose (at least 4 sessions)\] / \[number of randomized participants in treatment arm\]

Time frame: At the post-treatment assessment (occurring at approximately 10 weeks)

Session Attendance

For enrolled participants, attendance rates will be calculated as \[number of visits attended\] / \[number of total visits\]

Time frame: At the post-treatment assessment (occurring at approximately 10 weeks)

Implementation Assessment Measure

Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.

Time frame: At the post-treatment assessment (occurring at approximately 10 weeks)

Secondary Outcomes

Change in Fatigue Severity Scale

Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.

Time frame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

Change in PROMIS Sleep Related Impairment 8 item

Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment

Time frame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

Central Contacts

Jessica R Dietch, PhD

CONTACT

541-737-1358 jessee.dietch@oregonstate.edu

Lucy Kozii, MD, MPH

CONTACT

koziil@oregonstate.edu

Data from ClinicalTrials.gov

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